Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of a topical estradiol gel for treatment of postmenopausal symptoms

Conditions: Hot Flashes

Summary: the purpose of this study is to determine the efficacy and safety of a topical estradiol gel for the treatment of hot flushes in postmenopausal women.

estrogens are a group of hormones that play an important role in normal sexual and reproductive development in women. estrogens serve many functions in the body. they stimulate oocyte maturation and endometrial growth, decrease bone resorption, initiate the development of secondary sex characteristics, maintain reproductive organs and glands, and affect the activity of the central nervous system. at menopause, the decrease in estrogen concentrations is often accompanied by vascular instability (hot flushes and night sweats), a rise in the incidence of heart disease, and an increasing rate of bone loss. estrogen is available as an oral drug, a transdermal patch, or as a gel or lotion. transdermal estrogen is preferable as compared to oral, since it avoids the first-pass metabolism in the liver. since release of the whi findings, current treatment recommendations are for the lowest effective dose for the shortest period of time to treat postmenopausal symptoms. comparison: three doses of a transdermal estradiol gel as compared to placebo for the treatment of vasomotor and vulvovaginal atrophy symptoms in postmenopausal women.

Eligibility criteria:
inclusion criteria: * postmenopausal women * serum estradiol level less than or equal to 20 pg per ml * serum fsh greater than 40 miu per ml exclusion criteria: * pathological cancer findings on screening * abnormal endometrium * serious hepatic, renal or cardiac disease

Keywords: hot flush hot flash estrogen vaginal atrophy
diagnostic performance of noninvasive fractional flow reserve from computed tomography

Conditions: Coronary Artery Disease

Summary: fractional flow reserve derived from computed tomography(ffrct) is a novel method for determining the physiologic significance of coronary artery disease (cad), which will help physicians in clinical decision-making and decrease the medical cost, but its ability to identify patients with ischemia has not been adequately examined to date.

fractional flow reserve derived from computed tomography(ffrct) is a novel method for determining the physiologic significance of coronary artery disease (cad), which will help physicians in clinical decision-making and decrease the medical cost, but its ability to identify patients with ischemia has not been adequately examined to date. available data from registered clinical trials has testified the diagnostic performance of ffrct, but the diagnostic accuracy among them are not consistent. thus, the investigators designed a collaborative individual patient-data pooled-analysis aimed to assess the diagnostic accuracy of ffrct and find the possible cause for inconsistency

Eligibility criteria:
inclusion criteria: * coronary computed tomographic angiography(ccta) with over 50 percent stenosis in a major coronary artery over 2mm diameter * undergoing clinically indicated invasive coronary angiography with ffr exclusion criteria: * a history of cabg surgery * prior percutaneous coronary intervention with suspected instent restenosis * suspicion of or recent acute coronary syndrome * complex congenital heart disease * prior pacemaker or defibrillator * prosthetic heart valve * significant arrhythmia * heart rate \>100 beats/min * systolic blood pressure≤90 mmhg * contraindication to beta blockers, nitroglycerin or adenosine * serum creatinine level greater than 1.5 mg per dl * allergy to iodinated contrast * pregnant state * body mass index greater than 35 * evidence of active clinical instability or lifethreatening disease * canadian cardiovascular society class iv angina * nonevaluable ccta as determined by the ccta core laboratory * inability to adhere to study procedures

Keywords: ffr fractional flow reserve ct computed tomography
comparing manual versus stapled side to side ileocolic anastomosis in crohn's disease

Conditions: Crohn Disease; IBD; Ileocolitis; Crohn's Ileocolitis

Summary: research question are handsewn (end to end and kono s side to side) anastomoses superior to side to side stapled anastomosis after ileocolic resection for crohn's disease with respect to endoscopic recurrence, gastrointestinal function and costs. hypothesis stapled side anastomosis advised in ecco guidelines heal with ulcerations on the staple line causing systematic over scoring of endoscopic recurrence leading to unjustified restarting of expensive drugs reducing qol and increasing costs. side to side saccular configuration causes stasis affecting recurrence and dysfunction. design randomised superiority study population patients with crohn requiring (re)resection of the (neo)terminal ileum intervention kono s and end to end hand sewn anastomosis usual care side to side stapled anastomosis outcome endoscopic recurrence (local and central reading) at 6 months sample 25% reduction in 2:1 ratio -\> 126 + 63 = 189 patients keywords crohn, ileocolic resection, recurrence


Eligibility criteria:
inclusion criteria: * males and females aged \>18 years * ileocolic disease or disease of the neoterminal ileum with an indication for resection * concurrent therapies with corticosteroids, 5-asa drugs, thiopurines, mtx, antibiotics, and anti-tnf therapy are permitted. * all patients should have undergone a colonoscopy and mr enterography (or ct enterography if mr contraindicated) in last 3 months to assess extent of disease. * ability to comply with protocol. * competent and able to provide written informed consent. * patient must have been discussed in the local mdt exclusion criteria: * inability to give informed consent. * patients less than 16 years of age. * patients undergoing repeated ileocolic resection. * history of cancer \< 5 years which might influence patients prognosis * emergent operation. pregnant or breast feeding.

Keywords: recurrence ibd ibd endoscopic recurrence rurgeers score surgical recurrence crohn's ileocolitis ileocolic anastomosis crohn's disease
exogenous ketones and behavior

Conditions: Behavior

Summary: the study will examine the effect of exogenous ketone ester on behavior and metabolism using virtual reality and computerizes behavioral tasks.

this study investigates the effects of exogenous ketone ester on behavior, cognition, and metabolism over one week of consumption. using a within-subjects, randomized, crossover design, participants will undergo two phases: one with the ketone ester supplement and one with a calorie- and taste-matched placebo. the study includes four lab visits: visits 1 and 3 mark the first day of each intervention, while visits 2 and 4 mark the last day. during each visit, participants will complete behavioral tasks, questionnaires, and blood tests. additionally, participants will record their food intake via an app and collect stool samples throughout the intervention.

Eligibility criteria:
inclusion criteria: * consent to participate * fluent in german * physically healthy. no regular medication * no drug use 1 week prior to the study * bmi 18-31 kg/m2 exclusion criteria: * former or current illnesses of: * brain or mind (including eating disorders, personality disorders, alcohol, drugs or drug dependence, neurological disorders other than occasional headache; depression or anxiety disorder excluded) * heart or blood circulation * gastro-intestinal or endocrine disorders * liver or kidney disorders * electrolyte imbalance * other serious past or present medical conditions (for example, metabolic syndrome, diabetes, cancer) * pregnancy * extreme athletes (\>2h/day intense work-out; casual cycling or walking is ok) * menopause (post menopause is ok) * ketogenic diet, ketogenic supplement intake, intermittent fasting or calorie restricted diet during preceding 4 weeks of study participation * fear of blood draw

Keywords: ketones human cognition metabolism anxiety intervention
efficacy and safety of a 7.5% icodextrin peritoneal dialysis solution in once-daily long dwell exchange

Conditions: Chronic Kidney Disease; Peritoneal Dialysis

Summary: the purpose of this study is to evaluate the efficacy and safety of a 7.5% icodextrin peritoneal dialysis solution for once-daily long dwell exchange in patients undergoing continuous ambulatory peritoneal dialysis (capd) in chinese uremic patients.patients were divided into dianeal group or extraneal group for long dwell time. net ultrafiltration, small solute clearance and relationship between different transport group were used to evaluate efficacy of icodextrin. physical examination, vital signs and laboratory tests were used to evaluate safety of icodextrin.

a prospective, multicenter, randomized, double blind, parallel controlled study has been conducted for 5 weeks in 201 capd patients. these patients were randomized from 7 centers with 98 allocated to the icodextrin group and 103 to the dextrose group. before study, conventional glucose-based solution was the only dialysate which can available in china. extraneal® is one of peritoneal dialysate produced by baxter which contains 7.5% icodextrin. patients involved the study were allocated to dianeal group and extraneal group in randomize. in dianeal group, prescription was unchanged, while in extraneal group, extraneal dialysate was used instead of 2.5% dianeal. assessments at baseline, week 2, and week 4 included drain volume and levels of glucose, creatinine, and urea in the dialysate drained from the long dwell; physical examination; vital signs; drained body weight; laboratory analyses. daily net peritoneal ultrafiltration, daily peritoneal creatine clearance and daily peritoneal urea nitrogen clearance were recorded prior to and 2 week, 4 week after commencing extraneal.

Eligibility criteria:
inclusion criteria: 1. patients undergoing continuous ambulatory peritoneal dialysis (capd) for more than 90 days were included in the study. 2. over the age of 18 3. received a minimum of 6-8 liters of dialysis fluid per day and nighttime must lasted for 8-16 hours with 2.5% dianeal® pd-2 or pd-4 dialysate, dwell volume was 2.0 liters before 30 days of screen visit 4. no acute/chronic exit infection or tunnel infection accompany with peritonitis infection before 30 days of screen visit exclusion criteria: 1. be sensitive to icodextrin 2. suffer from other serious disease 3. attended other invention research which was approved by ethics committee 4. used other drugs in trial 30 days before screen visit.

Keywords: icodextrin ultrafiltration creatinine clearance urea nitrogen clearance
factors affecting patient participation in aids malignancy clinical trials consortium clinical trials

Conditions: HIV Infection; Malignant Neoplasm; Precancerous Condition

Summary: this pilot research trial studies factors affecting patient participation in acquired immune deficiency syndrome (aids) malignancy clinical trials consortium clinical trials. determining how patients makes decisions about participating in a clinical trial may help doctors plan clinical trials in which more patients are willing to participate and are satisfied with their decision to participate.

primary objectives: i. to identify participant-level factors affecting recruitment of potentially eligible participants in aids malignancy clinical trials consortium (amc) studies at core and affiliated sites. secondary objectives: i. to describe the socio-demographic characteristics for participation and non-participation in amc clinical trials among all approached volunteers across amc sites. ii. to characterize socio-demographic characteristics with motivation and decision making among those who consented to participate in an amc trial. iii. to identify the perceived barriers associated with clinical trial participation among those who did not consent to participate in an amc clinical trial. iv. to better understand how potential study volunteers learn about amc clinical trials and by what means are they referred to a particular study. outline: participants complete the improving participation in amc clinical trials (impacts) survey comprising questions about socio-demographic information and clinical trial participation.

Eligibility criteria:
inclusion criteria: * hiv-infected participants * cancer or anal dysplasia diagnosis * offered informed consent on an amc interventional clinical trial * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * inability to provide informed consent
investigation of the effect of geriatric massage

Conditions: Nursing Caries

Summary: there is no study has been found to examine the effect of geriatric massage applied to the elderly with type 2 diabetes on diabetes symptoms and blood parameters. this study was planned as a pretest-posttest randomized controlled single-center study to examine the effect of geriatric massage on diabetes symptoms and blood parameters in the elderly with type 2 diabetes. 60 elderly people who type 2 diabetes who applied to the internal medicine polyclinic of bayburt state hospital in the city center of bayburt will the diagnosis of type 2 diabetes will form the sample of the study. the sample will consist of two groups, the geriatric massage group and the control group. data will be collected with the "elderly information form", "standardized mini-mental test", "diabetes symptoms checklist scale", "blood parameters monitoring form". "geriatric massage" will be applied as an intervention. the geriatric massage group will receive 20 minutes (10 minutes on each foot) foot massage and 10 minutes back massage, two days a week for eight weeks. the control group will receive the institution's standard of care. frequency, number, mean, student's t test and/or mann-whitney u test, anova and/or kruskal-wallis test, chi-square test and/or correlation and regression analysis will be used in the analysis of the data. as a result of this study, it is anticipated that the effects of geriatric massage on diabetes symptoms and blood parameters in the elderly with type 2 diabetes will be determined and these effects will be included in evidence-based guidelines.


Eligibility criteria:
inclusion criteria: * age 65-84 * no visual or hearing impairment * ability to communicate verbally * applying to bayburt state hospital internal medicine polyclinic * having a diagnosis of type 2 diabetes for at least six months * a score of 25 and above on the standardized mini mental test * agreeing to participate in the research exclusion criteria: * having vascular disease (thrombus, phlebitis, arterial embolism, severe venous ulceration) * having heart failure, pacemaker and neurological disease * body temperature being higher than 37.5°c for more than two days, suspected or diagnosed with inflammation * having acute pain * cancer and undiagnosed malignancies, receiving chemotherapy and radiotherapy * presence of any scar tissue, chronic inflammatory skin diseases on the back * having foot amputation, fracture, infection, wound, skin disease, pathology and neuropathy related to muscles and bones

Keywords: blood parameters elderly geriatric massage symptom type 2 diabetes
effect of smoking cessation on clinical and microbiological outcomes of the non-surgical periodontal therapy

Conditions: Periodontitis

Summary: the aim of this prospective interventional study is to verify the efficacy of smoking cessation on clinical and microbiological outcomes of non-surgical periodontal therapy of chronic periodontitis patients. smokers willing to quit received periodontal treatment and concurrent smoking cessation therapy. periodontal maintenance was performed every 3 months. a single calibrated examiner, blinded to smoking status, assessed periodontal clinical outcomes and applied a structured questionnaire in order to collect demographic and behavioural information. further, expired carbon monoxide concentration were measured with a monoximeter. a pooled subgingival plaque sample was collected from the deepest periodontal pocket from each participant. the presence and quantification of aggregatibacter actinomycetemcomitans, porphyromonas gingivalis, tannerella forsythia and treponema denticola were determined using (rt-pcr).

smokers willing to quit, with 10 teeth or more, and with periodontitis (30% or more of their teeth with proximal attachment loss ≥ 5 mm) were enrolled in the study. all subjects received periodontal treatment and concurrent smoking cessation therapy. smoking cessation therapy was performed by a team comprising physicians, nurses, a psychologist and dentists, and consisted of four 1-h counselling lectures, psychologist-assisted cognitive behavioral therapy, nicotine replacement therapy and medication (bupropion or varenicline). smoking cessation motivation was reinforced by dentists at the maintenance sessions, by means of motivational interviewing techniques. periodontal therapy consisted in full-mouth supra and subgingival scaling and root planing (with curettes and ultrasonic scaler); oral hygiene instruction and motivation and removal of intra-oral plaque retentive factors. further, periodontal maintenance was performed every 3 months. a single calibrated examiner, blinded to smoking status, assessed periodontal clinical outcomes (recession, pocket depth, clinical attachment level, plaque index and bleeding on probing). a structured questionnaire was applied in order to collect demographic and behavioral information. expired carbon monoxide concentration was measured with a monoximeter, in order to validate smoking status. a pooled subgingival plaque sample was collected from the deepest periodontal pocket from each participant. the presence and quantification of aggregatibacter actinomycetemcomitans, porphyromonas gingivalis, tannerella forsythia and treponema denticola were determined using real time - pcr (rt-pcr).

Eligibility criteria:
inclusion criteria: * smokers willing to stop smoking * \>10 teeth * periodontitis (30% or more of their teeth with proximal attachment loss ≥ 5 mm) exclusion criteria: * systemic conditions considered as risk factors for periodontal disease, * periodontal therapy in the last 6 months * continuous systemic use of anti-inflammatory or steroidal drugs

Keywords: smoking cessation tobacco periodontal subgingival microorganisms
high-field mri iron-based contrast-enhanced characterization of multiple sclerosis and demyelinating diseases

Conditions: Multiple Sclerosis

Summary: feraheme (ferumoxytol) is fda-approved for iron supplementation and is composed of iron oxide nanoparticles classified among the ultra-small superparamagnetic iron oxides (uspio). in this project we hypothesize that feraheme could become a sensitive and specific marker of active inflammation in multiple sclerosis. we will explore this hypothesis taking advantage of ultra high field strength (7t) mri to further increase the effectiveness of the contrast agent feraheme at revealing inflammatory activity.

multiple sclerosis (ms) is a neurological disorder that affects young adults world-wide. feraheme (ferumoxytol) is fda-approved for iron supplementation and is composed of iron oxide nanoparticles classified among the ultra-small superparamagnetic iron oxides (uspio). after iv injection, the particles are taken up by the monocyte-macrophage system and can also be used to track macrophage infiltration by magnetic resonance imaging (mri) after systemic injection owing to the strong image contrast of the iron-loaded macrophages. approximately 24 hours after their iv injection, free particles are cleared from the circulation and mr signal alterations are thought to arise from the capture of particles by circulating phagocytic cells that are attracted to inflammatory lesions. in this project we hypothesize that feraheme could become a sensitive and specific marker of active inflammation in multiple sclerosis. we will explore this hypothesis by taking advantage of ultra high field strength (7t) mri to further increase the effectiveness of the contrast agent feraheme at revealing inflammatory activity.

Eligibility criteria:
inclusion criteria: * patients will be included if they are at least 18 years old and meet the revised diagnostic criteria for multiple sclerosis, relapsing remitting type. * patients will be included based on mr evidence of disease activity after gadolinium (enhanced lesion) on a previous screening mr in the previous 3 weeks days before feraheme administration. exclusion criteria: * children (age \< 18) * those who lack decision-making capability * contraindication to mri such as pacemaker, other mr-incompatible metal implants or claustrophobia * known allergy to dextran or drugs containing iron salts or any previous history of severe allergic reactions * evidence of iron overload such as hemochromatosis or other hematologic disorders that imply iron level superior to the normal level. * pregnancy or breast feeding. * history of renal disease or estimated glomerular filtration rate (egfr) using the modification of diet in renal disease (mdrd) \<40ml/min/1.73m?

Keywords: multiple sclerosis mri uspio ferumoxytol feraheme
safety profile of applied 100% manuka honey in tympanoplasty

Conditions: Chronic Suppurative Otitis Media; Tympanic Membrane; Wound

Summary: throughout history, honey has been recognized for its healing properties. the use of honey for its medicinal properties dates back to 2200 bce. the purpose of this clinical trial is to learn about the otological safety of 100% medical grade manuka honey given to tympanoplasty patients the main question it aims to answer is: can 100% medical grade manuka honey given at the time of tympanoplasty otologically safe? participants in the intervention group will receive a wound dressing of 100% medical grade manuka honey after reconstructive surgery of the tympanic membrane. researchers will compare the intervention group to the control group assess otological safety.

the aim of the present study is to conduct a randomized clinical trial to evaluate the otological safety of 100% medical grade manuka honey on the tympanic membrane post tympanoplasty compared to the control group. the investigation will involve 64 participants with chronic suppurative otitis media of the mucosal type, who will be randomly put into two groups (intervention or control), where the intervention group will receive a dressing of 100% sterile manuka honey during surgery. results of this study will inform practitioners as to the otological safety of 100% sterile manuka honey on the tympanic membrane.

Eligibility criteria:
inclusion criteria: * participants of 18 - 45 years of age. * participants with chronic suppurative otitis media of the mucosal type. * provision of signed and dated informed consent form. stated willingness to comply with all study procedures and availability for the duration of the study. exclusion criteria: * participants who previously received surgical therapy for chronic suppurative otitis media or have recurrent or residual disease. * participants with anatomical pathology results showing and/or suspecting a tumor.

Keywords: chronic suppurative otitis media manuka honey tympanic membrane otologic safety